[Recalled] Xlumena brand NAVIX Access Device, Model/Catalogue Number: NVX-10-03, Part Number: FG-00666, Product is manufactured and distributed by Xlumena, Inc., Mountain View, CA The NAVIX Access Device is a multi-lumen balloon catheter
Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.
Recall details
| Product | Xlumena brand NAVIX Access Device, Model/Catalogue Number: NVX-10-03, Part Number: FG-00666, Product is manufactured and distributed by Xlumena, Inc., Mountain View, CA The NAVIX Access Device is a multi-lumen balloon catheter with a trocar, anchor balloon, and dilation balloon that creates and d |
|---|---|
| Brand / manufacturer | Xlumena, Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-2167-2013 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 17 April 2013 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: A complaint investigation has found that product fractures can occur at the distal end of the catheter under load.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.